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What is the most important information I should know about metformin and rosiglitazone?

Taking metformin and rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, metformin and rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

You should not use this medication if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you advanced heart failure, kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and rosiglitazone.

Before taking metformin and rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What is metformin and rosiglitazone?

Metformin and rosiglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Metformin and rosiglitazone is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Taking metformin and rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, metformin and rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Metformin and rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Metformin and rosiglitazone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking metformin and rosiglitazone?

Some people develop a life-threatening condition called lactic acidosis while taking metformin and rosiglitazone. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

You should not use this medication if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you have:

advanced heart failure; or

kidney disease;

if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and rosiglitazone.

To make sure you can safely take this medication, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes.

FDA pregnancy category C. It is not known whether metformin and rosiglitazone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Some women using metformin and rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking metformin and rosiglitazone. Talk with your doctor if you are concerned about this possibility.

It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take metformin and rosiglitazone without first talking to your doctor if you are breast-feeding a baby.

How should I take metformin and rosiglitazone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take metformin and rosiglitazone with meals, especially during the first few weeks of therapy.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking metformin and rosiglitazone for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may have you take extra vitamin B12 while you are taking metformin and rosiglitazone. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking metformin and rosiglitazone?

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis while taking metformin and rosiglitazone.

What are the possible side effects of metformin and rosiglitazone?

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effects, such as:

These lists are not complete and there are many other medicines that can increase or decrease the effects of metformin and rosiglitazone on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about metformin and rosiglitazone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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